Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV

NCT03289676 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2017147
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

HIV has transformed into a chronic illness due to the advent of effective treatments in the absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs), including lung cancer, has increased three-fold among people living with HIV. NADCs now account for 50% of all cancers among the people. Smoking is one of the major contributing factors to lung cancer and smoking prevalence is substantially higher in this population than the general U.S. population. Smoking prevalence does not differ by gender among people living with HIV. Women of color, particularly African American women represent the majority of women living with HIV (WLHIV) followed by Latinas. WLHIV smoke at a rate almost 3 times higher than that for the general U.S. female population (e.g., 42% vs. 16%). The proposed study has two phases: 1) the development of a storytelling narrative communication (SNC) intervention that will be added to an established HIV-tailored smoking cessation intervention and 2) a two-arm randomized controlled trial (RCT) of the HIV-tailored intervention plus the SNC Intervention compared with the HIV-tailored intervention only. The investigators will develop narrative videos with three to five WLHIV who will be talking about their personal struggles with smoking and success in quitting. Preliminary study revealed that the established HIV-tailored intervention was effective only for short-term (≤ 2 months) abstinence. Many relapsed to smoking between the 2nd and 6th month of quitting. The investigators propose that the SNC intervention will be an effective strategy to sustain their quit efforts for long-term abstinence (≥ 6 months). A total of 60 WLHIV will be recruited and randomly assigned to either the experimental arm (a combination of HIV-tailored and SNC interventions) or the control arm (HIV-tailored intervention only). Specific aims of the study are to 1) Identify SNC intervention components that are rated high in transport and identification for use as an enhancement to an HIV-tailored smoking cessation intervention; 2) Determine the feasibility and acceptability of the SNC intervention for WLHIV by assessing the rate of recruitment and retention for feasibility and the degree of transport and identification for acceptability; and 3) Establish an effect size of HIV-tailored and SNC interventions for smoking cessation in comparison with the HIV-tailored smoking cessation intervention only for WLHIV, for subsequent grant applications.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• Adherence Rate

  Women in both arms who reported having watched all four videos of the storytelling narrative intervention.

  3 months

• 3-month Abstinence Rate

  Participants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.

  3 months

Secondary Outcomes (1)

• Self-efficacy in Resisting Smoking Temptation.

  3 months

Study Arms (2)

Quitting Smoking Video

EXPERIMENTAL

This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.

Combination Product: Storytelling Narrative Intervention

HIV Infection Video

ACTIVE COMPARATOR

This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.

Combination Product: Storytelling Narrative Intervention

Interventions

Storytelling Narrative Intervention COMBINATION_PRODUCT

In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.

Also known as: Cognitive Behavioral Counseling, Nicotine Replacement Therapy

HIV Infection Video; Quitting Smoking Video

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Who are biologically females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women who:
• are able to speak English
• self-report HIV infection and submit a supplementary document if necessary
• are between the ages of 18 and 65
• have been smoking at least 5 cigarettes a day for the past 6 months
• own a mobile phone with an access to a video call application such as Skype, Imo, Tango, and Face Time
• are willing to quit smoking within the next 4 weeks from the baseline assessment; and
• agree to use an approved form of birth control (e.g., oral medications, condoms, and intrauterine devices) during the study period.

You may not qualify if:

• Women who:
• are not able to speak English
• are pregnant or lactating
• have an active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders Identification Test59)
• self-report currently receiving treatment for a serious mental illness (e.g., schizophrenia and bipolar disorder) or
• currently use any illegal substances excluding marijuana.

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

University Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Related Publications (3)

• Kim SS, DeMarco RF. The Intersectionality of HIV-Related Stigma and Tobacco Smoking Stigma With Depressive and Anxiety Symptoms Among Women Living With HIV in the United States: A Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):523-533. doi: 10.1097/JNC.0000000000000323. Epub 2022 Jan 7.

  PMID: 34999667 DERIVED

• Kim SS, Cooley ME, Lee SA, DeMarco RF. Prediction of Smoking Abstinence in Women Living With Human Immunodeficiency Virus Infection. Nurs Res. 2020 May/Jun;69(3):167-175. doi: 10.1097/NNR.0000000000000421.

  PMID: 31977840 DERIVED

• Kim SS, Lee SA, Mejia J, Cooley ME, Demarco RF. Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV. Ann Behav Med. 2020 May 25;54(6):447-454. doi: 10.1093/abm/kaz062.

  PMID: 31863582 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Sun Kim
• Organization: UNIVERSITY OF MASSACHUSETTS BOSTON

sun.kim@umb.edu

6172875372

Study Officials

• Sun S Kim

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person who assesses follow-up assessments will be blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: : The proposed study has two phases. 1. Phase 1. Development of Narrative Video: We will first develop narrative videos in collaboration with community organizations of WLHIV in Boston. The video will be filmed in person at the University of Massachusetts Boston. 2. Phase 2. A Randomized Controlled Trial (RCT) of a Story Telling Narrative Communication Intervention: We will conduct a two-arm RCT assigning participants at a ratio of 1:1 to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control: HIV-tailored plus attention-control interventions). Both arms will have eight weekly sessions of a 30-minute HIV-tailored cessation intervention (cognitive behavioral therapy plus nicotine patches). All research-related procedures will be conducted remotely.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 21, 2017
• Study Start: September 6, 2017
• Primary Completion: October 23, 2018
• Study Completion: November 1, 2018
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)